Corrective and Preventive Action (CAPA) & Batch Documentation by d.velop Life Sciences GmbH

When it co­mes to GxP-com­pli­ant do­cu­men­ta­ti­on so­lu­ti­ons, d.velop Life Sci­en­ces GmbH is your ex­pe­ri­en­ced con­ta­ct. Whe­ther phar­maceu­ti­cal in­dus­try, me­di­cal tech­no­lo­gy, dia­gnostics, he­alth­ca­re sec­tor, food in­dus­try, steel in­dus­try or con­tract ma­nu­fac­tu­ring we of­fer you in­di­vi­du­al so­lu­ti­ons – from Batch Do­cu­men­ta­ti­on and Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tion (CAPA), Do­cu­ment Con­trol, Trai­ning Ma­nage­ment, De­via­ti­on Con­trol (DC) and Pro­cess Do­cu­men­ta­ti­on to Con­tract Ma­nage­ment and Chan­ge Ma­nage­ment (CC). Learn more about our pro­fes­sio­nal soft­ware so­lu­ti­on for CAPA.

We de­ve­lop and mar­ket in­no­va­ti­ve soft­ware for the end-to-end di­gi­tiz­a­ti­on of your busi­ness pro­ces­ses and in­dus­try-spe­ci­fic spe­cia­li­zed pro­ce­du­res. We fo­cus on the con­trol of re­cords and ar­chi­ving, the con­trol of do­cu­ments as well as pro­duc­tion-re­la­ted QM processes.

Nu­me­rous sa­tis­fied cus­to­mers al­rea­dy trust in our com­pre­hen­si­ve so­lu­ti­ons and our ex­cel­lent ser­vice. Feel free to re­quest a de­tail­ed con­sul­ta­ti­on and com­pre­hen­si­ve in­for­ma­ti­on about our di­gi­tiz­a­ti­on solutions.

You can re­ach us by te­le­pho­ne un­der 02542 — 20201 0 as well as via our con­ta­ct form. We look for­ward to your in­qui­ry and will be glad to help you in a com­pe­tent and friend­ly manner.

Digital Corrective and Preventive Actions (CAPA)

Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CAPA) pro­vi­des high data in­te­gri­ty. CA­PAs are no lon­ger lost be­cau­se they are stored elec­tro­ni­cal­ly from the be­gin­ning. Mo­reo­ver, a high le­vel of tracea­bi­li­ty is pro­vi­ded – sin­ce CA­PAs can be lin­ked to other mo­du­les such as Chan­ge Con­trol, an ea­si­ly trace­ab­le chain of in­ter­re­la­ted in­di­vi­du­al pro­ces­ses is crea­ted. CA­PAs can be in­itia­ted, for ex­amp­le, from de­via­ti­on re­ports or the can in­itia­te a chan­ge process.

A high le­vel of pro­cess re­lia­bi­li­ty is en­su­red by the fact that the CAPA is for­war­ded to the re­spec­ti­ve per­son re­spon­si­ble for the re­spec­ti­ve sub­ject af­ter each step – if time li­mits are ex­cee­ded, the es­ca­la­ti­on sys­tem steps in. Trans­pa­ren­cy is crea­ted by al­lowing every aut­ho­ri­zed em­ployee to see the cur­rent sta­tus of all CAPA pro­ces­ses – even if he or she is not in­vol­ved in the pro­cess. Mo­reo­ver, re­ports and sta­tis­tics can be ge­ne­ra­ted about your CAPAs.

Our soft­ware en­ab­les you to crea­te ef­fec­ti­ve CA­PAs that you can ea­si­ly mo­ni­tor and con­trol digitally.

Re­gu­la­to­ry re­qui­re­ments are for example:

Digital Batch Documentation

CAPA is clo­se­ly lin­ked to di­gi­tal Batch Do­cu­men­ta­ti­on. You no lon­ger need sto­rage space for pa­per. The si­gna­tu­re is ap­p­lied elec­tro­ni­cal­ly – the­re­fo­re a ma­nu­al trans­port of the batch file is no lon­ger ne­cessa­ry. Fur­ther­mo­re, the QP can re­lease the batch do­cu­men­ta­ti­on from his mo­bi­le de­vice. The au­to­ma­ti­cal­ly ge­ne­ra­ted batch file con­tains all in­for­ma­ti­on at a glance. Mo­reo­ver, our di­gi­tal Batch Do­cu­men­ta­ti­on al­lows all aut­ho­ri­zed em­ployees to view all batch do­cu­ments trans­par­ent­ly — even when they are on the road.

The di­gi­tal batch do­cu­men­ta­ti­on sup­ports you in batch-ori­en­ted scan­ning. It is also pos­si­ble to au­to­ma­ti­cal­ly trans­fer me­ta­da­ta to the scan­ned do­cu­ment. Ad­ding to this, our so­lu­ti­on en­ab­les un­al­terable elec­tro­nic sto­rage in ac­cordance with the re­ten­ti­on pe­ri­ods spe­ci­fied by the re­gu­la­to­ry aut­ho­ri­ties and op­tio­nal main­ten­an­ce of your batch record.

Re­gu­la­to­ry re­qui­re­ments are for example:

Individual digitization solutions for every need

From cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA), Batch Do­cu­men­ta­ti­on, Do­cu­ment Con­trol, Trai­ning Ma­nage­ment and De­via­ti­on Con­trol (DC) to Pro­cess Do­cu­men­ta­ti­on, Con­tract Ma­nage­ment and Chan­ge Con­trol (CC), we are your ex­pe­ri­en­ced part­ner for in­di­vi­du­al di­gi­tiz­a­ti­on so­lu­ti­ons. Our pro­ducts have been suc­cess­ful­ly au­di­ted in TÜV au­dits ac­cord­ing to the gui­de­li­nes of the ISO stan­dards 9001 and 13485 as well as du­ring in­spec­tions of the re­gio­nal coun­cil (Ger­ma­ny) and can be in­di­vi­du­al­ly ad­ap­ted to the lifecy­cle of your spe­ci­fi­ca­ti­on do­cu­ments and forms.

Al­rea­dy more than 8,500 cus­to­mers world­wi­de suc­cess­ful­ly use our ba­sic pro­duct d.3 as a cen­tral ECM/DMS/archive sys­tem. If you ar­chi­ve your do­cu­ments with d.3 life sci­en­ces, quo­ta­ti­ons, in­voices and de­li­very no­tes as well as ma­nu­fac­tu­ring or test pro­to­cols can be stored in the cen­tral di­gi­tal ar­chi­ve in com­pli­an­ce with re­gu­la­to­ry re­qui­re­ments such as GoBD or GxP.

Con­ta­ct us for a de­tail­ed con­sul­ta­ti­on. We would be glad to take some time for your ques­ti­ons and con­cerns and of­fer you many ye­ars of ex­pe­ri­ence and know-how.

Are you looking for a solution for your CAPA processes?

Then take a look at our so­lu­ti­on now